– First-in-human clinical trial of MyopiaX®, the first therapeutic approach in juvenile myopia to target the dopamine pathway digitally
– Enrollment ongoing in Germany, Spain, the Netherlands, and the United Kingdom
Dopavision, a clinical-stage company developing innovative solutions for the management of myopia, today announced an update on its MyopiaX-1 trial (NCT04967287). All clinical trial centers are now open and are actively screening and enrolling study participants, providing trial access to eligible children with myopia across Germany, Spain, the Netherlands, and the United Kingdom.
The trial is designed to evaluate the safety, tolerability, and signals of clinical effect of MyopiaX®, an innovative therapeutic intervention developed by Dopavision’s scientists and digital technology experts for the management of pediatric myopia.
The MyopiaX-1 clinical trial is based on extensive preclinical and translational research that provided the background for the study’s regulatory submissions and approvals. MyopiaX-1 is a randomized, active-controlled clinical trial, enrolling children with progressive myopia between the ages of 6 and 12 years and a refractive error between –0.75 and –5.00 Diopters. The trial is conducted in accordance with GCP guidelines. Dopavision is developing MyopiaX® as an active medical device.
“MyopiaX is designed as a non-invasive therapy to trigger an increase in the eye’s natural production of dopamine, a molecule known to be involved in regulating eye growth,” said Mark Wuttke, CEO of Dopavision. “It is a light-based therapeutic technology that non-pharmacologically modulates the eye’s innate dopamine pathway. We believe MyopiaX has the potential to be the first clinically validated digital myopia intervention to target this key biological mechanism in the growing eye.”
“The MyopiaX-1 trial will provide the first clinical insights into this unique therapeutic approach to manage the progression of juvenile myopia,” said Prof. Ian Flitcroft, Principal Investigator at the Centre for Eye Research Ireland. “Using blue light to modulate the dopamine pathway in myopic eyes offers the potential for a novel, additional therapeutic option for myopia control.”
The coordinating center of the MyopiaX-1 clinical protocol is led by Prof. Ian Flitcroft and Prof. James Loughman of the Centre for Eye Research Ireland at the Technological University of Dublin in Ireland. The study rationale and design were presented at the European Society of Ophthalmology’s (SOE) Congress on June 15, in Prague. First results from the study are expected to be available in early 2024.
Dopavision is set to develop disruptive treatments for dopamine-related pathologic conditions, using light and digital technologies. Its first mission is to provide an innovative, clinically validated intervention rooted in the science of dopamine to manage myopia progression, an increasing public health concern around the globe. Dopavision is backed by top-tier international investors such as Seventure Partners, Novartis Pharma (dRx Capital), Boehringer Ingelheim Venture Fund, and Ababax.Health and is supported by the German government via the “Industrie-in-Klinik” program of the German Federal Ministry of Education and Research BMBF.